ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manu
FDA device recall Z-2073-2012 · posted 2012-07-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
- Action taken
- The firm issued "Urgent: Medical Device Correction" letters delivered by the Siemens Customer Service Group or by certified mail to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm stated that release of this UI TH018/12/S to distribute the notifications began on June 25, 2012.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 18
- Distribution
- Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.
- Date initiated
- 2012-06-25
- Date posted
- 2012-07-24
- Date terminated
- 2012-10-18
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE SOLUTION WITH SYS_VB50 UPDATE (K103606) | Siemens Medical Solutions USA, Inc. | 2011-04-15 |